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Evaluation of Dyskinesias in a Pilot, Randomized, Placebo-Controlled Trial of Remacemide in Advanced Parkinson Disease
Parkinson Study Group
Arch Neurol. 2001;58:1660-1668.
Context Long-term levodopa therapy for Parkinson disease commonly results in
motor complications including "on-off" fluctuations and dyskinesias, but it
is still unclear how best to assess treatment effects on dyskinesias in clinical
trials.
Objective To compare several methods of rating levodopa-induced dyskinesias to
evaluate the effect of remacemide hydrochloride treatment in patients with
advanced Parkinson disease.
Design Two-week multicenter randomized, double-blind, placebo-controlled, parallel-group
study.
Setting Five academic sites of the Parkinson Study Group.
Patients Thirty-nine subjects at least 30 years old with idiopathic Parkinson
disease and disabling dyskinesias.
Interventions Randomly received daily doses of 150 mg, 300 mg, or 600 mg of remacemide
hydrochloride or matching placebo for 2 weeks.
Main Outcome Measures The dyskinesia rating scales used were the Modified Goetz Dyskinesia
Rating scale (MGDRS), a newly created Lang-Fahn Activities of Daily Living
Dyskinesia scale (LFADLDS), and diary dyskinesia ratings.
Results Patient and investigator diaries showed excellent agreement in dyskinesia
ratings. The MGDRS score correlated with clinic diary ratings of the percentage
of "on" time with dyskinesias, and the LFADLDS score correlated with home
and clinic diary assessments of percentage of on time with severe dyskinesias.
The MGDRS score did not correlate highly with the LFADLDS score. This pilot
study also validated previous results demonstrating the safety and tolerability
of remacemide treatment for advanced Parkinson disease but did not result
in any demonstrable improvement or worsening in dyskinesia measures.
Conclusions Diaries may provide a valid means of evaluating dyskinesias in clinical
trials for Parkinson disease, but there remain other aspects of dyskinesias,
as assessed by the MGDRS and LFADLDS, that are not reflected in diary ratings.
This study was supported in part by Astra Pharmaceuticals, Wayne, Pa;
by grant M01-RR00044 to the General Clinical Research Centers at the University
of Rochester, from the National Institutes of Health, Bethesda, Md; and by
a National Parkinson Foundation Center of Excellence at the University of
Rochester.
Corresponding author: J. Antonelle de Marcaida, MD, Department of
Neurology, Hartford Hospital, 80 Seymour St, Hartford, CT 06102 (e-mail: jdemarc{at}harthosp.org).
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